ScientistFUJIFILM Diosynth Biotechnologies U.S.A.
Morrisville, NC Full-time
Posted on July 7, 2019
SCIENTIST- MORRISVILLE, NC: Dvlp & qualify assays fr characterization & id, purity, & strength assessment of recombinant protein drugs. Provide sample testing supp, ind gen of analysis reports. Plan, conduct, evaluate, & interpret lab experiments. Execute complex analytics. Assist w/ method troubleshooting & investigations. Maint lab equip. Eval accuracy of data to ensure integrity. Train jr scientists. Lead OpEx initiatives. Create Std Work Elements. Write ref material qualification doc. Dvlp new analytical methods using statl approach. Supp tech transfer into QC. Participate in reg audit supp. Reqts: Master's or equiv in Pharm Sci, Biotech, or reltd, & 1 yr exp in protein analytical position or reltd, incl 1 yr exp w/: Applying instrumentation, comp sys's & softw fr data acquisition & analysis, incl Empower, SoftMax Pro, or Empower Method Validation Mgr; Perf statl analysis using softw, incl SAS JMP, Fusion QbD, or Excel; Working in reg GMP env; Analyzing proteins, troubleshooting protein-based analytics, & method qualif and/or validation in 3 of following fields: UPLC/HPLC (using Empower 3), peptide map, N-glycan analysis, capillary electrophoresis (using Maurice or PA800 systems), gel electrophoresis, western blot, or spectrophotometry; Transferring methods into QC env. FDBU works w/ technl data, tech & materials that are subject to U.S. export laws & regs. This position will require access to techl data, tech & source code that is controlled under U.S. export laws & regs, incl but not limited to Internat'l Traffic in Arms Regs at 22 CFR Parts 120 130 & Export Admin Regs in 15 CFR Part 730 774, as may be amended. To conform to these laws & regs, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees & refugees) or otherwise eligible for an export authorization from the U.S. Dept of State or U.S. Dept of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization. FDBU is an EOE. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. Mail resume to FUJIFILM Diosynth Biotechnologies U.S.A. Inc. (FDBU), ATTN: HR, 101 J. Morris Commons Lane, Morrisville, NC 27560.